Quality and Regulatory Compliance Director – Biopharma

Quality and Regulatory Compliance Director - Biopharma

Job Type: permanent
Salary: Competitive
Posted: 10th July 2019
Ref: CRBG - QARACOM

Responsibilities

Quality Strategy & Management Systems

  • Contribute to the development of company’s Quality policy and strategy, and to the installation of Best Practices for Quality in the company.
  • Develop a strategic Quality plan for Company, ensure implementation, and contribute effectively to the strategic development as part of the TPO Leadership Team.
  • Establish and ensure that appropriate Quality standards are applied to the products and to the Manufacturing (specific to Investigational Medicinal Products and Preclinical Products) and Development Operations in accordance with Regulatory requirements and applicable Quality Standards.
  • Ensure the development, efficient operation and maintenance of the Quality Systems, particularly concerning deviations (Unplanned Events, Out Of Specifications), Internal and External Audit, Change Control, Complaints, Documentation, Validation & Qualification, Regulatory Compliance of Operations.
  • Develop & maintain relationships with Regulatory Authorities and lead the inspection process for Quality.
  • Enhance the reputation of Company with external partners, authorities and the general public.

Operational Product Quality

  • Ensure that the Quality review, release and disposition of Finished Investigational Medicinal Products (subcontracted), APIs, Raw Materials and Components is performed according to GxP requirements.
  • Ensure compliance of raw materials (i.e. polymers, solvents, excipients) / API sourcing, and DP development and manufacturing operations versus cGMP requirements.
  • Ensure implementation of recall /complaint management system and processes for clinical batches.
  • Ensure appropriate implementation of deviation and change control processes related to regulatory and clinical batches.

Quality Team Management

  • Recruit, lead, manage and develop the Quality & Regulatory Compliance team.
  • Establish Quality objectives and KPIs for Company and TPO. Ensure these objectives are met and that Continuous Improvement is demonstrated.
  • Accountable for Quality budget, i.e. propose and manage the overall Quality department budget, ensuring activities are managed in a cost effective manner in line with the approved budget.
  • Ensure the effectiveness of the GxP training program for TPO staff and any relevant Company staff.
  • Ensure that an effective Company Quality Management Review process is in place and running.
  • Provide Quality representatives for Drug Development project teams.
  • Encourage best practices, ways of working, specifically encouraging the use of Enterprise Excellence Risk Management and Continuous Improvement.

Qualification/Validation & Infrastructure Compliance

  • Provide Regulatory support for the regulatory status of the site documentation (site master file maintenance, import / export licenses …) and for certification of Finished Product batches.
  • Ensure compliance of process validation and analytical methods validation, as well as management of deviations and change controls related to equipment and facilities.
  • Set-up and ensure implementation of procedures for metrology, calibration and validation of equipment.
  • Provide Regulatory Compliance input for filing and maintenance of Pharmaceutical Establishment dossier.

Vendors & Internal audits

  • Ensure that a vendor agreement process and management system is in place and run effectively.
  • Ensure that an external and internal audit process and management system is in place and running effectively
  • Ensure that appropriate Quality Technical Agreement (QTA) process is in place and implemented according to the procedures
  • Develop solid relationships with potential suppliers (drug substance, copolymers, etc.) and CMOs to ensure compliance of CMC activities
  • Ensure Quality relationship with Company strategic partners in the context of Product Development & IMP supply.
  • Develop & maintain relationships with Regulatory Authorities and lead the inspection process for Quality.
  • Enhance the reputation of Company with external partners, authorities and the general public.

Requirements

  • Ideally PharmD or PhD in pharmaceutical science with industrial pharmaceutical focus. `
  • Minimum 5 years’ experience as a Quality & Regulatory manager in the pharma/biopharma industry.
  • Strong knowledge of all manufacturing site activities in the context of product development including IMP manufacturing, QC testing, packaging and distribution, proven experience in Pharmaceutical development, full awareness of EMA and FDA requirements for IMPs and INDs development and manufacturing.
  • Proven experience of department management and interactions with Regulatory authorities and bodies.
  • Currently working as a Qualified Person in pharma/biopharma industry.
  • Ideally Lean Six Sigma certified (Yellow or Green Belt).
  • Experience in international and multidisciplinary teams
  • Demonstrated ability and conceptual knowledge to produce high quality regulatory documents and presentations to effectively communicate in a clear, organized and concise manner to agencies and senior management for decision-making.

General work attitude

  • Effective functioning in a rapidly changing environment and adherence to the values, principles and mission of the company.
  • Resilience and ability to deal effectively with demanding and stressful situations.
  • Proficiency in self-learning new skills, tools and software.
  • Desire to solve complex problems and ability to put in place and lead specific task forces for this goal.
  • Excellent interpersonal skills and an ability to work with others in a highly collaborative environment.
  • Strong work ethic.
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